HEADON ULTIMATE RELIEF- iris versicolor root and bryonia alba root stick 
American Health Distributions Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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HEADON®

Drug Facts

Active IngredientsPurpose
Iris versicolor (Blue flag) 12X H.P.U.S. 0.2%Pain Reliever
Bryonia alba (White bryony) 12X H.P.U.S. 0.08%Pain Reliever

The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Use

Warnings

For external use only

Do not use if you are allergic or hypersensitive to any ingredient in this product, have sensitive skin or any skin disease.

Ask a doctor before use if you have

  • never had migraines diagnosed by a health professional
  • a headache that is different from your usual migraines
  • the worst headache of your life
  • headaches beginning after or are caused by head injury, exertion, coughing or bending
  • experienced your first headaches after the age of 50
  • daily headaches
  • migraine headaches so severe as to require bed rest
  • fever and stiff neck

When using this product

  • avoid contact with eyes, wounds, mucous membranes, broken or irritated skin
  • do not share this product with anyone
  • do not apply a heating pad to forehead
  • irritation or allergic reaction may occur with some people. Test by applying product to a small area of the forehead and wait 30 minutes. If skin appears normal, proceed with Directions.

Stop use and ask a doctor if

  • skin redness or irritation develops
  • an allergic reaction occurs. Seek medical help right away.
  • migraine headache pain worsens or continues for more than 48 hours
  • new or unexpected symptoms occur
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store between 15° and 30° C (59° and 86° F).

Inactive Ingredients

diazolidinyl urea, ethyl alcohol, iodopropynyl butylcarbamate, menthyl lactate, propylene glycol, sodium stearate, steareth-21, tetrasodium EDTA, triethanolamine, water

Dist. by Miralus Healthcare
Cheyenne, WY 82001

Questions ?

call 1-877-373-3436, Weekdays 9AM to 5PM EST or visit us online at www.miralus.com

PRINCIPAL DISPLAY PANEL - 5.67 gram canister carton

NEW

Apply directly
to forehead

HEADON®
Headache Relief

ULTIMATE RELIEF

Headache & Migraine Reliever

PRINCIPAL DISPLAY PANEL - 5.67 gram canister carton
HEADON  ULTIMATE RELIEF
iris versicolor root and bryonia alba root stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67567-0306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root12 [hp_X]
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
diazolidinyl urea (UNII: H5RIZ3MPW4)  
alcohol (UNII: 3K9958V90M)  
iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
menthyl lactate (UNII: 2BF9E65L7I)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium stearate (UNII: QU7E2XA9TG)  
EDETATE sodium (UNII: MP1J8420LU)  
trolamine (UNII: 9O3K93S3TK)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67567-0306-11 in 1 CARTON
11 in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC06/01/2010
Labeler - American Health Distributions Inc. (010328220)
Establishment
NameAddressID/FEIBusiness Operations
CPC Laboratories Inc.026453260MANUFACTURE, LABEL, PACK

Revised: 6/2010
Document Id: ccd725b8-1d98-4864-9429-b27d8498e7fe
Set id: 10d39efd-f61e-46df-bd70-26d2ad80a703
Version: 1
Effective Time: 20100610
 
American Health Distributions Inc.